Completed

NCT Number: NCT01386320

Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery

Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks have been used for many years to help alleviate pain following this surgery. The present study aims to compare a new ultrasound guided nerve block to a well established nerve stimulator guided technique. Comparisons will include time taken to carry out the block, speed of onset of numbness and duration and quality of pain relief after surgery.

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Key information

Conditions

Pain Relief After Forefoot Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Castle Hill Hospital, Castle Road, Cottingham

Hull, East Yorkshire, HU16 5JQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Fit adult patients requiring forefoot surgery with bone cutting.

Exclusion criteria

Morbid obesity (BMI >40), known contraindications to regional anaesthesia

Treatment and study plan

Ultrasound guided ankle block

Procedure

Under ultrasound guidance, block of the tibial nerve, superficial and deep branches of the common peroneal nerve and saphenous nerves will be carried out using 12 mls 0.5% levobupivacaine and 12 mls 0.75% levobupivacaine.

Medial forefoot block

Procedure

Using peripheral nerve stimulator guidance, the tibial and common peroneal nerves will be blocked ( plus the saphenous nerve ), using a total of 12 mls 0.75% levobupivacaine and 12 mls 0.5% levobupivacaine.

Primary outcomes

Time taken to carry out each local anaesthetic block

Time frame: Over forty five minutes from the start of the study.

Time taken between opening sterile packs and completion of local anaesthetic block is measured by a blind observer.

Secondary outcomes

Onset of local anaesthesia

Time frame: Over thirty minutes from completion of the local anaesthetic block.

Following administration of the local block, development of anaesthesia will be measured looking at cold and pin-prick sensation by a blind observer.
Duration of pain relief following local anaesthetic block.

Time frame: Over 24 hours following surgery.

Pain relief will be assessed over 24 hours following surgery, to assess its duration and quality, by a blind observer.

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

A Randomised, Blinded Comparison of an Ultrasound Guided Ankle Block Compared to a Nerve Stimulator Guided Ankle Block for Pain Relief After Forefoot Surgery.

Acronym: USGAB

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jul 1, 2011
Registry last updated: Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.